Bone Level Healing Abutment 4035-3HA

GUDID D78540353HA0

4mm Healing Abutment 4mm Diameter 3mm Height

OCO BIOMEDICAL INC

Dental implant system

• Primary Device ID: D78540353HA0
• NIH Device Record Key: 13a6955e-79e4-4041-b56b-e817bfa08441
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bone Level Healing Abutment
• Version Model Number: 4mm Healing Abutment
• Catalog Number: 4035-3HA
• Company DUNS: 094146123
• Company Name: OCO BIOMEDICAL INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D78540353HA0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090174

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[D78540353HA0]

Moist Heat or Steam Sterilization

[D78540353HA0]

Moist Heat or Steam Sterilization

[D78540353HA0]

Moist Heat or Steam Sterilization

[D78540353HA0]

Moist Heat or Steam Sterilization

[D78540353HA0]

Moist Heat or Steam Sterilization

[D78540353HA0]

Moist Heat or Steam Sterilization

[D78540353HA0]

Moist Heat or Steam Sterilization

[D78540353HA0]

Moist Heat or Steam Sterilization

[D78540353HA0]

Moist Heat or Steam Sterilization

[D78540353HA0]

Moist Heat or Steam Sterilization

[D78540353HA0]

Moist Heat or Steam Sterilization

[D78540353HA0]

Moist Heat or Steam Sterilization

[D78540353HA0]

Moist Heat or Steam Sterilization

[D78540353HA0]

Moist Heat or Steam Sterilization

[D78540353HA0]

Moist Heat or Steam Sterilization

[D78540353HA0]

Moist Heat or Steam Sterilization

[D78540353HA0]

Moist Heat or Steam Sterilization

[D78540353HA0]

Moist Heat or Steam Sterilization

[D78540353HA0]

Moist Heat or Steam Sterilization

[D78540353HA0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-04-13

On-Brand Devices [Bone Level Healing Abutment]

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• D78550455HA0: 5mm Healing Abutment 5mm Diameter 5mm Height
• D78550453HA0: 5mm Healing Abutment 5mm Diameter 3mm Height
• D78540355HA0: 4mm Healing Abutment 4mm Diameter 5mm Height
• D78540353HA0: 4mm Healing Abutment 4mm Diameter 3mm Height
• D785325305HA0: 3.25mm Healing Abutment 3.25mm Diameter 5mm Height
• D785325303HA0: 3.25mm Healing Abutment 3.25mm Diameter 3mm Height